title: Better reporting and greater homogeneity in outcome measures are seen in randomized trial protocols when guidelines exist.
abstract: OBJECTIVE
  Outcome Measures in Rheumatology promotes standardized outcome measures. No such organization exists for nephrology. We compared the reporting and homogeneity of outcome measures in registered protocols of randomized trials in rheumatology and nephrology.
  
  
  METHODS
  Data were extracted from protocols for rheumatoid arthritis or nephroprotection registered in ClinicalTrials.gov. We rated five outcome items (domain, specific measurement, specific metric, method of aggregating data, and time frame) to obtain a 5-point score. We split outcomes into clusters that could be pooled for meta-analysis, and assessed the proportion of trials and patients by cluster.
  
  
  RESULTS
  We selected 75 protocols for rheumatology and 66 for nephrology. A high adjusted score for outcomes was associated with rheumatology protocols (odds ratio, 4.2; 95% confidence interval, 2.39, 7.39). We retained 13 clusters of outcomes for rheumatology, and one of one outcome (American College Rheumatology Criteria) could pool 87.1% of trials and 92.8% of patients. We retained eight clusters for nephrology, and one of four outcomes (assessing proteinuria) could pool 83.1% of trials and 44.7% of patients.
  
  
  CONCLUSIONS
  The reporting and homogeneity of outcomes is better in registered protocols of rheumatology than nephrology. The presence of international guidelines on outcome measurement may explain the differences.
authors.affiliation: INSERM U738, Paris, France.
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Sautenet
authors.forename: Agnès
authors.initials: A
authors.lastname: Caille
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Halimi
authors.forename: Philippe
authors.initials: P
authors.lastname: Goupille
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
mesh_terms: D002985:Clinical Protocols / Q000592:standards*; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D006801:Humans; D016015:Logistic Models; D015201:Meta-Analysis as Topic; D009398:Nephrology; D017063:Outcome Assessment, Health Care / Q000592:standards* / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012219:Rheumatology